Trial record 15 of 27 for:    "Chordoma"

Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00349024
First received: July 5, 2006
Last updated: September 19, 2013
Last verified: June 2009
  Purpose

RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis, or mouth sores, in patients undergoing treatment for cancer.

PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer.


Condition Intervention
Brain and Central Nervous System Tumors
Chordoma
Kidney Cancer
Leukemia
Lymphoma
Mucositis
Neuroblastoma
Pain
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: polyvinylpyrrolidone-sodium hyaluronate gel

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Timing and intensity of oral pain
  • Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
  • Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
  • Symptoms, other than pain, considered important to the pediatric population

Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy.

OUTLINE: This is a prospective, uncontrolled, open-label, pilot, multicenter study.

Beginning before hospital discharge or day 3 after chemotherapy, patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute, 3 times per day or as needed. Treatment continues for 48 hours. Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours.

Oral pain and acceptability (i.e., taste) of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   4 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer, including, but not limited to, the following:

    • Acute lymphoblastic leukemia
    • Acute myeloid leukemia
    • Brain tumor
    • Hodgkin's lymphoma
    • Non-Hodgkin's lymphoma
    • Sarcoma
    • Wilms' tumor
    • Neuroblastoma
  • Meets 1 of the following criteria:

    • Admitted to an in-patient unit after undergoing chemotherapy that is anticipated to cause oral mucositis
    • Admitted to an in-patient unit after undergoing myeloablative therapy followed by peripheral blood stem cell or bone marrow transplantation
  • Is experiencing oral pain due to mucositis

PATIENT CHARACTERISTICS:

  • No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent analgesics allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349024

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Investigator: Faith Gibson, MD Great Ormond Street Hospital for Children NHS Foundation Trust
Investigator: Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00349024     History of Changes
Other Study ID Numbers: CDR0000481526, CCLG-SC-2005-07, EU-20621
Study First Received: July 5, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chordoma
unspecified childhood solid tumor, protocol specific
pain
childhood acute lymphoblastic leukemia
childhood Hodgkin lymphoma
chondrosarcoma
osteosarcoma
childhood soft tissue sarcoma
Wilms tumor and other childhood kidney tumors
neuroblastoma
childhood acute myeloid leukemia/other myeloid malignancies
childhood large cell lymphoma
childhood lymphoblastic lymphoma
childhood small noncleaved cell lymphoma
childhood rhabdomyosarcoma
childhood brain stem glioma
childhood central nervous system germ cell tumor
childhood cerebellar astrocytoma
childhood cerebral astrocytoma/malignant glioma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoma
childhood medulloblastoma
childhood meningioma
childhood oligodendroglioma
childhood atypical teratoid/rhabdoid tumor
childhood spinal cord neoplasm
childhood supratentorial primitive neuroectodermal tumor
childhood visual pathway and hypothalamic glioma
mucositis

Additional relevant MeSH terms:
Chordoma
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Lymphoma
Nervous System Neoplasms
Neuroblastoma
Stomatitis
Central Nervous System Neoplasms
Mucositis
Sarcoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Germ Cell and Embryonal
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on April 17, 2014